Shortcomings in drug recall notifications and the solution
Several news agencies are reporting on a recent study of the efficacy of the FDA system of communicating drug and product recalls to consumers.
The FDA recalls potentially harmful drugs about once every month, but according to a recent study conducted over the last eight years, they could be doing a better job of letting doctors and patients know about them.
Over that period, researchers found that the FDA failed to send notifications for 20 percent of the most serious recalls through its system used to alert doctors and the public who know about, and subscribe to, that electronic notification system…and how many of us subscribe to that?
According to the FDA, Class I recalls are issued for drugs that have the potential to cause “serious adverse health consequences or death.” if taken by unsuspecting patients.
Joshua Gagne, from Brigham and Women’s Hospital in Boston stated that between 2004 and 2011, he and his fellow researchers counted more than 1,700 drug recalls listed in the FDA’s enforcement reports. Of those, 91 were serious Class I recalls.
During that time, the FDA issued about 2,900 announcements through the Recall Alert System, which sends notifications to subscribers about recalled drugs and products. The system, however, only sent alerts for 55 of the 91 Class I recalls.
The problem is a serious and obvious one. If the dangers of defective drugs are not adequately communicated to those that may be endangered by them, what is the point of recalling them?
It seems to me that the solution is as obvious as the problem. Once the FDA issues a recall, shouldn’t the company with the defective drug be responsible for making sure no one is hurt by their mistake? That is how it works for the rest of us (who do not have lobbyists). If your dog is dangerous and you know it, you have a responsibility to keep people away from him. If you don’t, you are strictly liable for any damage he causes. Why should it be different for big drug companies? Put the burden on the people that caused the problem to prevent further damage. The drug company should contact all of the doctors and patients that have their product and warn them about the defect. And they need to be incentivized. They should not be allowed to argue that the injured person should have known better than to take the drug just because the FDA recalled it. And I promise that is what happens in every litigation over defective drugs. The drug company tried to cut off claims brought by people it knows were injured by its product because they “adequately warned of the danger” through the recall. Now it is obvious that the FDA does not communicate every serious recall. Moreover, the FDA’s electronic method doesn’s inform the actual patients who are taking the drug. It is time to take the responsibility of informing consumers about defective products off the government and on the companies that caused the problem in the first place.
If our government wants to be part of the solution, take away the current protections the drug companies have. Make them strictly liable for damage their defective products cause. Eliminate the argument that some victims should not be able to bring a claim because a warning was issued by the FDA. The company either tells the potential victim themselves or suffers the financial consequences in litigation.